Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Baseline inflammation has been shown to influence response to tumor necrosis factor alpha antagonist treatment in patients with axial spondyloarthritis (SpA). This study evaluated the role of C-reactive protein (CRP) in the response to treatment with infliximab (IFX)+nonsteroidal anti-inflammatory drugs (NSAIDs) vs NSAIDs alone in patients with axial SpA who had early, active disease.
Methods: Part 1 of the INFAST trial was a double-blind, randomized controlled trial of IFX in biologic-naïve patients 18–48 years of age with early, active axial SpA (Assessment of SpondyloArthritis international Society [ASAS] criteria, disease duration ≤3 years, chronic back pain, and active inflammation of the sacroiliac [SI] joints on magnetic resonance imaging [MRI]). Patients naïve to NSAIDs or treated with a submaximal dose of NSAIDs were randomized (2:1) to receive 28 weeks of treatment with either intravenous (IV) IFX 5 mg/kg (weeks 0, 2, 6, 12, 18, and 24)+naproxen (NPX) 1000 mg/d or IV placebo (PBO)+NPX 1000 mg/d. ASAS partial remission was evaluated in patients with high CRP (>upper limit of normal [ULN], per local laboratory limits) or low CRP (≤ULN). Response was also evaluated in patients who met the New York modified criteria for ankylosing spondylitis (AS) by SI X-ray (bilateral ≥grade 2 or unilateral ≥grade 3, based on local rheumatologist judgement) and were not naïve to NSAIDs (AS group) versus patients with nonradiographic axial SpA (nr-axSpA group). Data were analyzed descriptively.
Results: 156 patients were included in efficacy analyses. Overall, ASAS partial remission rate was greater for the IFX+NPX group (n=105) than the PBO+NPX group (n=51) (61.9% vs 35.3%, P=0.0021). For patients treated with IFX+NPX, partial remission rate was greater in the 49 patients with high CRP than in the 44 with low CRP (71.4% vs 59.1%). However, for patients treated with NPX alone, partial remission rates were similar whether CRP was high or low (40.7% [n=27] vs 38.5% [n=13]). In analysis of the AS and nr-axSpA groups, partial remission was greater in the AS group than the nr-axSpA group after treatment with IFX+NPX (72.2% [n=54] vs 56.4% [n=39]); after treatment with NPX alone, partial remission was greater in the nr-axSpA than the AS group (46.7% [n=25] vs 36.0% [n=15]). This pattern might be explained by the higher baseline mean CRP values in the AS group (n=83) than the nr-axSpA group (n=63) (CRP 2.59 vs 0.92 mg/dL). Within the AS group, the difference between the 2 treatments was clear in patients with high baseline CRP (IFX+NPX, 75.8% [n=33] vs NPX, 30% [n=20]); but not with low baseline CRP (IFX+NPX, 66.7% [n=21] vs NPX, 60% [n=5]). This pattern was not observed in the nr-axSpA group, perhaps because of low baseline CRP or because of the small number of subjects available for analysis.
Conclusion: In this population of axial SpA patients with early disease and established MRI inflammation at baseline, elevated baseline CRP was associated with a better response to IFX therapy.
Disclosure:
J. Sieper,
Abbott, Merck, Pfizer, Janssen; Consultant for Abbott, Merck, Pfizer, UCB, Roche, Lilly, Novartis,
2,
Merck, Abbott, Pfizer, UCB,
8;
M. Rudwaleit,
Abbott, BMS, MSD, Pfizer, UCB,
5,
Abbott, BMS, MSD, Pfizer, UCB, Roche ,
8;
J. Lenaerts,
Abbott, BMS, MSD, Pfizer, Roche, Astra Zeneca,
8;
J. Wollenhaupt,
AbbVie, Biotest, BMS, Chugai, MSD, Medac, Merck, MSD, Pfizer, Roche, UCB, Astra Zeneca, and Sanofi,
5,
AbbVie, Biotest, BMS, Chugai, MSD, Medac, Merck, MSD, Pfizer, Roche, UCB, Astra Zeneca, and Sanofi,
8;
L. Myasoutova,
None;
S. Park,
None;
Y. Song,
None;
R. Yao,
Merck Sharp & Dohme,
3;
M. Govoni,
Merck Sharp & Dohme,
3;
D. Chitkara,
Merck Sharp & Dohme,
3;
N. Vastesaeger,
Merck Sharp & Dohme,
3.
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